Antimicrobial Effect of Different Pastes on Streptococcus Mutans in Children

Oral Health Clinical Trial

Official title:

Antimicrobial Effect of Casein Phosphopeptide Amorphous Calcium Phosphate on Streptococcus Mutans in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03526315
• Other study ID #: JUST
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: October 2016

Study information

• Verified date: May 2018
• Source: Jordan University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a randomized controlled trial involving 127 children ages between 4 and 5 years to investigate the efficacy of Casein Phosphopeptide-Amorphous Calcium Phosphate (CPP-ACP) in reducing Streptococcus mutans (S. mutans) bacteria, and compare that with fluoride alone, or combined use of fluoride and CPP-ACP over a 6 month period using Saliva Check Mutans kits to detect Mutans Streptococci (MS). It is expected that all used anti-cariogenic agents will have the ability to reduce the S. mutans level in different values.

Description:

Aim: The aim of this study is to investigate the efficacy of CPP-ACP in reducing S. mutans, and compare that with fluoride alone, or combined use of fluoride and CPP-ACP.

Materials and methods: This study is a randomized controlled trial involving 127 children ages between 4 and 5 years. They will be examined and chosen randomly for the study. One hundred and twenty seven children will be divided equally into three groups: Group 1 will use CPP-ACP twice daily, Group 2 will apply fluoride toothpaste twice daily, Group 3 will apply fluoridated toothpaste and CPP-ACP twice daily. Oral swabs will be collected from children to measure S. mutans levels in terms of Colony forming units (CFU) using Saliva Check Mutans kits (GC© , Asia) for this purpose. Samples will be analyzed for S. mutans colonization before antibacterial agent application (baseline) and at 3, and 6 month intervals.

Expected results: it is expected that all used anti-cariogenic agents will have the ability to reduce the S. mutans levels in different levels.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 5 Years

Eligibility

Inclusion Criteria:

• Healthy 4-5 years old children, with primary dentition, and early childhood caries/high risk caries

Exclusion Criteria:

• Milk protein (casein) sensitivity

• Patient who has taken antibiotics in the last month

• Lack in cooperation in oral examination

• Medically compromised children

• Children that have received fluoride supplement or professional topical fluoride application at least three months before or during the study period.

Related Conditions & MeSH terms

• Mutans Streptococci
• Oral Health

Intervention

Other:
• CPP-ACP paste
Children will brush their teeth with CPP-ACP paste twice daily.
• Fluoride toothpaste
Children will brush their teeth with fluoridated toothpaste twice daily.
• Both (Fluoride and CPP-ACP)
Children will brush their teeth with fluoridated toothpaste and apply CPP-ACP immediately after tooth brushing, twice daily.

Locations

Country	Name	City	State
Jordan	Jordan University of Science and Technology	Irbid

Sponsors (1)

Lead Sponsor	Collaborator
Jordan University of Science and Technology

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Streptococcus mutans levels (Colony Forming Units/CFU) using Saliva Check Mutans kits ( GC, Asia)	Changes in Streptococcus mutans after use of CPP-ACP, Fluoride or both Saliva Check Mutans kits ( GC, Asia)	3 and 6 months
Secondary	Changes in caries using the decayed, missing due to caries, filled, deciduous teeth (dmft index)	Changes in dmft after use of CPP-ACP, Fluoride or both agents over 3 and 6 months.	3 and 6 months
Secondary	Changes in caries using the decayed, missing due to caries, filled, deciduous tooth surfaces (dmfs) index	Changes in dmfs after use of CPP-ACP, Fluoride or both agents over 3 and 6 months.	3 and 6 months
Secondary	Changes in caries using the International Caries Detection and Assessment System (ICDAS) scores	Changes in ICDAS scores over 3 and 6 months.	3 and 6 months